Maintenance Of Quality Of Life Research Articles

Predictors of Quality of Life among Older Residents in Rural and Urban Areas in Indonesia: An Approach Using the International Classification of Functioning, Disability, and Health.

The International Classification of Functioning, Disability, and Health (ICF) model provides a comprehensive framework for understanding health and quality of life (QoL) in older adults in both rural and urban settings, each presenting unique advantages and challenges. This study aimed to explore the relationship between factors based on the ICF model and QoL among older residents of these areas. A cross-sectional study was conducted, involving 286 older adults aged 60 years or older from rural and urban areas of Surakarta, Central Java, Indonesia. The WHOQoL-BREF was utilized to assess QoL. The co-factors included personal factors, impairments, and activity limitations. Multiple linear regression analysis indicated that lower limb muscle strength was the most significant factor associated with QoL in older adults in rural areas (B=0.681, standard error [SE]=0.301, p=0.026), followed by static balance (B=0.085, SE=0.034, p=0.014). In urban areas, gender emerged as the most significant factor influencing QoL (B=-13.643, SE=2.499, p<0.001), followed by hemoglobin level (B=-1.847, SE=0.760, p=0.017), age (B=-0.935, SE=0.246, p<0.001), and cognitive function (B=0.493, SE=0.179, p=0.007). Efforts to improve QoL for older adults in rural areas should focus on enhance physical performance through exercise. In urban areas, the maintenance of QoL is influenced by personal factors. It is crucial to address physical performance through exercise to enhance QoL in rural settings. Meanwhile, focusing on mental health, financial security, and social connections is recommended to improve QoL for older adults in urban areas.

Атипичная форма болезни Хираяма (клиническое наблюдение)

Hirayama disease (HD), known as monomelic amyotrophy, is a rare benign disease. Typically, it represents progressive predominantly unilateral atrophy of mainly distal muscles of the upper extremities in young Asian men. Although the disease pathogenesis is still unknown, most scientists assume that a discrepancy between lengths of the spinal cord and the spinal canal caused by a rapid increase in growth, plays a key role in its development. The clinical presentation of HD is characterized by a gradual (3-5 year-long) progression of weakness and muscular atrophy in the distal segments of predominantly one upper limb, symptom deterioration associated with cold exposure and absence of sensory impairments. Sometimes the disease demonstrates atypical symptoms. The main diagnostic method for HD is magnetic resonance imaging of the cervical spine in a flexion position; additionally, stimulation electroneuromyography is performed. Both conservative and surgical therapies are focused on symptom mitigation, rehabilitation and quality of life maintenance. KEYWORDS: Hirayama disease, myelopathy, monomelic amyotrophy, muscular atrophy. FOR CITATION: Kondratov A.A., Kotov A.S. Atypical Hirayama disease (case report). Russian Medical Inquiry. 2024;8(10):587–591 (in Russ.). DOI: 10.32364/2587-6821-2024-8-10-7

The impact of time length to Boolean remission for tight disease activity control after acquisition in rheumatoid arthritis patients

Clinical importance of time length from initiation under treat-to-target (T2T) strategy to acquisition of clinical remission (TL) in treating patients with rheumatoid arthritis (RA) on disease activity control, daily activities, and quality of life maintenance was investigated. In patients who achieved Boolean remission once or more, relationship between TL and patients’ background data at initiation, and relationship between TL and mean simplified disease activity score (SDAI), Health Assessment Questionnaire Disability Index (HAQ-DI) score, pain score with visual analog scale (PS-VAS), Sharp/van der Heijde Score (SHS) and quality of life score (QOLS) at the first remission and thereafter were evaluated statistically. Patients were divided into two groups whether TL was within 6 months or longer (G ≤ 6 and G > 6). Change of the parameters and Boolean remission rate (BRR) after the first remission between the two groups were compared statistically. In 465 patients, TL correlated significantly with the SDAI score, the HAQ score, PS-VAS, SHS, and the QOLS after the remission. The SDAI score and the BRR after the remission were significantly better in the G ≤ 6 than in the G > 6. TL is an important key to guarantee good and stable clinical course in treating under T2T.

Prevention of chemotherapy-induced neutropenia (CIN) with plinabulin (Plin) vs placebo (Plac) in patients (pts) with non-small cell lung cancer (NSCLC) treated with docetaxel (Doc): A pooled analysis from 3 randomized trials.

e21163 Background: CIN can lead to increased patient/healthcare burden, resource utilization, hospitalizations, and poorer quality of life (QoL). G-CSF has a high incidence of bone pain and mild thrombopenia and is given the day after chemo. Plin, a novel non-G-CSF small molecule, protects the bone marrow stem cell, has minimal bone pain, and protects platelet precursors. Plin is given on the same day as chemo and has NSCLC anticancer efficacy (ESMO 2021, Feinstein). The CIN effects of Doc plus Plin vs Doc with Plac were pooled from 3 NSCLC clinical trials. Methods: Data from randomized trials, phase (Ph) 3 trial 103 (NCT02504489), Ph2/3 trial 105 ( NCT03102606 ), and Ph2 trial 101 (NCT00630110) were pooled. Pts were randomized to either Doc (75mg/m2) plus Plin (20mg/m2 or its pharmacokinetic equivalent) (n = 146) or Doc plus Plac (n = 296). Doc was administered on day 1 of each 21-day cycle x 4 cycles, and Plin or Plac was administered ~30 minutes after Doc. Neutrophil counts were taken at predose and day (D) 8 of each cycle in studies 101 &amp; 103, and on predose, D1, 2, 6, 7, 8, 9, 10, 15, and 21 in study 105. Pts given G-CSF in D1-D3 were excluded. Duration of severe neutropenia (DSN) was calculated by methods previously reported (ASH 2022, Blayney). All Grade (Gr) and Gr4 neutropenia (N) rates, Absolute N count (ANC), febrile N (FN) rate, and ANC on D8 (‘nadir’) were obtained. QoL scores were obtained in studies 103 and 105 by EORTC QLQ-C30. Patient-reported adverse events (AEs) were collected. Results: Pt demographics were comparable. Plin was statistically and clinically significantly superior to Plac for All Gr and Gr4 N frequencies, Day 8 ANC (‘nadir’), and DSN (all had p &lt; 0.0001). Febrile Neutropenia (FN) and infection rates were numerically lower (see table). Fewer pts were treated with antibiotics among pts treated with Plin. Platelet count was unaffected with Plin; grade (gr) 3/4 thrombocytopenia was &lt; 1% with either Plin or Plac. The total frequency of treatment-emergent AEs for Plin vs Plac were 71% vs 80%. QoL scores were similar for Plin and Plac. Conclusions: In 3 independent randomized studies (101, 103, and 105), Plin demonstrated a superior benefit for CIN and showed clinical benefit for infection rate versus Plac. Additionally, Plin has the added benefits of pt convenience (same-day dosing and no additional visits or wearable device), a favorable safety and tolerability profile, anticancer efficacy, and QoL maintenance, which represents a distinct advantage over G-CSF. Clinical trial information: NCT02504489 ; NCT03102606 ; NCT00630110 . [Table: see text]

Efficacy and Safety of Darolutamide in Patients with Nonmetastatic Castration-resistant Prostate Cancer Stratified by Prostate-specific Antigen Doubling Time: Planned Subgroup Analysis of the Phase 3 ARAMIS Trial

BackgroundPatients with nonmetastatic castration-resistant prostate cancer (nmCRPC) have a high risk of progression to metastatic disease, particularly if their prostate-specific antigen doubling time (PSADT) is ≤6 mo. However, patients remain at a high risk with a PSADT of >6 mo. ObjectiveTo evaluate the efficacy and safety of darolutamide versus placebo in patients stratified by PSADT >6 or ≤6 mo. Design, setting, and participantsA planned subgroup analysis of a global multicenter, double-blind, randomized, phase 3 trial in men with nmCRPC and PSADT ≤10 mo was conducted. InterventionPatients were randomized 2:1 to oral darolutamide 600 mg twice daily or placebo, while continuing androgen-deprivation therapy. Outcome measurements and statistical analysisThe primary endpoint was metastasis-free survival (MFS). Secondary endpoints were overall survival (OS) and times to pain progression, first cytotoxic chemotherapy, and symptomatic skeletal events. Quality of life (QoL) was measured using validated prostate-relevant tools. Safety was recorded throughout the study. Results and limitationsOf 1509 patients enrolled, 469 had PSADT >6 mo (darolutamide n = 286; placebo n = 183) and 1040 had PSADT ≤6 mo (darolutamide n = 669; placebo n = 371). Baseline characteristics were balanced between subgroups. Darolutamide significantly prolonged MFS versus placebo in both subgroups (unstratified hazard ratio [95% confidence interval]: PSADT >6 mo, 0.38 [0.26–0.55]; PSADT ≤6 mo, 0.41 [0.33–0.52]). OS and other efficacy and QoL endpoints favored darolutamide with significant improvement over placebo in both subgroups. The incidence of adverse events, including events commonly associated with androgen receptor inhibitors (fractures, falls, hypertension, and mental impairment), and discontinuations due to adverse events were low and similar to placebo. Limitations include small subgroup populations. ConclusionsIn patients with nmCRPC and PSADT >6 mo (maximum 10 mo), darolutamide provided a favorable benefit/risk ratio, characterized by significant improvements in MFS, OS, and other clinically relevant endpoints; maintenance of QoL; and favorable tolerability. Patient summaryIn patients with prostate cancer that has stopped responding to standard hormonal therapy (indicated by an increase in prostate-specific antigen [PSA] levels), there is a risk that the cancer will spread to other parts of the body. This risk is highest when the time it takes for the PSA level to double (ie, “PSA doubling time” [PSADT]) is less than 6 mo. However, there is still a risk that the cancer will spread even if the PSADT is longer than 6 mo. In a group of patients whose PSADT was more than 6 mo but no more than 10 mo, treatment with darolutamide slowed the cancer spread and allowed them to live longer than patients who received placebo (inactive drug). Darolutamide treatment did not cause many side effects and helped maintain patients’ quality of life without disruptions.

Bone Health in Metastatic Cancer.

This article reviews the epidemiology and treatment of bone metastases. Also, it revisits the mechanism of action, indications, benefits, and complications of antiresorptive agents; discusses the adverse event profile of these agents; and addresses the prevention and management of these side effects. For this review, peer-reviewed articles, research publications, and relevant clinical guidelines identified from PubMed were used. Bone metastases are common in advanced cancer and much more frequently than in primary bone cancer, especially in adults. Bisphosphonates and Denosumab are potent antiresorptives and significantly reduce the risk of skeletal-related events. These complications are related to poor quality of life, bone pain, functional disability, and decreased survival. Prolonged therapy with these antiresorptive agents in patients with advanced malignancy is generally well tolerated, but some side effects are potentially serious and require periodic monitoring. Furthermore, some of them can be avoided. The role of health care providers and specially nurses on identifying patients at risk of complications from these antiresorptive agents, and providing information on how to prevent them, is essential for health and quality of life maintenance in these patients.

Quality of Life and Survival of Metastatic Colorectal Cancer Patients Treated With Trifluridine-Tipiracil (QUALITAS)

IntroductionThe RECOURSE trial demonstrated a modest benefit in overall survival (OS) for trifluridine/tipiracil (FTD/TPI) versus placebo in pretreated metastatic colorectal cancer (mCRC) patients. Unfortunately, quality of life (QoL) was not assessed. We evaluated QoL and survival of patients treated with FTD/TPI in daily practice. Patients and MethodsQUALITAS is a substudy of the Prospective Dutch CRC cohort (PLCRC). From 150 mCRC patients treated with FTD/TPI, QoL (EORTC QLQ-C30 and QLQ-CR29) was assessed monthly from study entry, and linked to clinical data of the Netherlands Cancer Registry. Joint models were constructed combining mixed effects models with Cox PH models. Primary endpoint was difference in QoL over time (which was deemed clinically relevant if ≥10 points). Secondary endpoints were progression-free survival (PFS), time to treatment failure (TTF), and OS. We analyzed the association between QLQ-C30 Summary Score (QoL-SS) at FTD/TPI initiation (baseline) and survival. ResultsThere was no clinically relevant change in QoL-SS from baseline to 10 months post-baseline (i.e. the cut-off point after which 90% of patients had discontinued FTD/TPI treatment): -5.3 [95% CI -8.7;-1.5]. Patients who were treated with FTD/TPI for ≥ 3 months (n = 85) reported 6.3 [1.6;11.1] points higher baseline QoL, compared to patients treated < 3 months (n = 65, “poor responders”). In the latter, time to a clinically relevant QoL deterioration was < 2 months. Median PFS, TTF and OS were 2.9 [2.7;3.1], 3.1 [2.9;3.2] and 7.7 [6.6;8.8] months, respectively. Worse baseline QoL-SS was independently associated with shorter OS (HR 0.45 [0.32;0.63]), PFS (0.63 [0.48;0.83]), and TTF (0.64 [0.47;0.86]). ConclusionThe maintenance of QoL during FTD/TPI treatment in daily practice supports its use. The QoL deterioration in “poor responders” is likely due to disease progression. The strong association between worse baseline QoL and shorter survival suggests that clinicians should take QoL into account when determining prognosis and treatment strategy for individual patients.

A telephone support program for patients with home enteral nutrition contributes to nutrition status and quality of life maintenance and reduces health resource use.

Appropriate patient/caregiver training and continuity of care after hospital discharge are key factors for the success of home enteral nutrition (HEN). This study aims to assess the effects of a specific patient support program (PSP) on the nutrition status, health-related quality of life (HRQoL), and healthcare resource utilization and associated costs of patients with HEN. Observational study of adult patients with HEN enrolled in a PSP. Sociodemographic variables (baseline), HRQoL (NutriQoL) and nutrition status (Mini Nutritional Assessment [MNA]) (baseline, 6 months after PSP enrollment), and use of unplanned HEN-related healthcare resources (6 months prior to or after PSP enrollment) were recorded. HEN-related resource cost was estimated from total resources used (all patients) and each resource cost. Data were analyzed with Stata program (v. 14), considering P < 0.05 as significant. Forty-three patients were included in the study (mean age, 72 years [SD = 21]; 54% women; mean HEN duration, 4 years [SD = 5]). A total of 401 calls were recorded in the PSP, 7% made proactively by the patient. HRQoL and nutrition status remained stable during the study period (NutriQoL baseline, 64; 6-months, 66; P = 0.3737; MNA baseline, 10; 6-months, 10; P = 0.0675). Unplanned resources amounted to €6229 (US $5563) and €4711 (US $4207) before and after PSP enrollment, respectively. Cost savings, representing €1518 (US $1356), were related to fewer emergency visits. Health advice provided through a PSP and close patient monitoring in the hospital can help to maintain patients' nutrition status and HRQoL and to reduce the use of certain unplanned HEN-related resources, leading to cost savings.

Long-Term Quality of Life and Audiometric Outcomes Following Noninvasive Stereotactic Radiosurgery for Acoustic Neuromas

Though microsurgery remains the most common method for management of acoustic neuromas (ANs), stereotactic radiosurgery continues to be a promising alternative. This study assesses long-term quality of life (QOL) outcomes and changes in hearing acuity in patents who have undergone single fraction Gamma Knife stereotactic radiosurgery (GKSRS) for AN.Prospective QOL outcomes were collected and analyzed to include Hearing Handicap Inventory (HHI), Dizziness Handicap Inventory (DHI), Tinnitus Handicap Inventory (THI), and 36-Item Short-Form Survey (SF-36) scores. Likewise, audiometric outcomes including speech discrimination (SD) and pure-tone average (PTA) were assessed. These data points were collected prior to and following GKSRS at regular intervals up to 5 years post-treatment. A mixed effects model for repeated measures was employed to assess QOL data for statistical significance.A total of 235 patients underwent GKSRS for AN at our institution from January 2007 to January 2017. Of these, 130 patients had available QOL and audiometric follow-up data and were included in this study. Median age was 60 y and median follow-up time was 36 mo. Median tumor size was 1.6 cm (0.1 - 3.6 cm), with median tumor volume of 0.552 cm3 (0.028 - 11.31 cm3), while median cochlear mean dose was 2.4 Gy (0 - 9.7 Gy). Baseline mean (median) HHI, DHI, THI, and SF-36 scores were 31.7 (28), 19.3 (12), 18.2 (12), and 70.0 (73.4) respectively. For each of these QOL metrics, mixed effects analysis indicated no statistically significant decline at any time point out to 5 years post-treatment. Indeed, 87% of patients had baseline SD and PTA scores available; 70% had follow-up SD and PTA available. Of these, 59% had baseline serviceable hearing (Gardner-Robertson score of I or II). Serviceable hearing was preserved in 71% of patients at 1 month, 79% at 6 months, 79% at 12 months, 62% at 18 months, 67% at 24 months, and 68% at 36 months.GKSRS provides long-term maintenance of QOL in the treatment of AN. HHI, DHI, THI, and SF-36 scores showed no significant decline up to 5 years post-radiosurgery. Patients with baseline serviceable hearing exhibited adequate hearing preservation.J.S. Lee: None. K.C. Lee: Royalty; Regents of the University of Michigan. Patent/License Fees/Copyright; Regents of the University of Michigan. D. Bojrab: None. P.Y. Chen: Stock; Greater Michigan Gamma Knife (GMGK). J. Jacob: None. I.S. Grills: Greater Michigan Gamma Knife.

Geriatric assessments and frailty scores in multiple myeloma patients: a needed tool for individualized treatment?

Purpose of reviewMultiple myeloma is a disease of elderly adults. Improvement in survival has occurred because of biological insights and novel agents. Therapeutic options involve choices today, thus have become more complex. Demographics have led to an increased number of elderly patients and age may be associated with a poorer outcome but is not the only prognostic predictor today.Recent findingsTo evaluate patients’ health status rather than their chronological age alone, frailty scores and functional geriatric assessments are used to identify prognostic groups, avoid adverse events, compare clinical trials and tailor treatment. As most clinical trials exclude frail elderly patients, those enrolled therein are often younger and healthier than the typical multiple myeloma patient. This represents a challenge for frail cohorts because of their increased risk of adverse events, overtreatment and undertreatment and/or therapy discontinuation, which may lead to poorer survival and quality of life (QoL). Reassessing patients’ status via geriatric assessments is also relevant during treatment to adjust interventions appropriately.SummaryIntegrating geriatric assessments may lead to individual treatment decisions, dose adjustments, better clinical outcome and QoL. Prospective clinical trials that enroll elderly multiple myeloma patients with comorbidities, incorporate frailty scores/geriatric assessments and help with prognostication, adverse event avoidance and QoL maintenance, remain warranted.

Health-related quality of life (QoL) in platinum-resistant ovarian cancer patients treated with olaparib and pegylated liposomal doxorubicin (PLD), a multicenter single-arm phase II clinical trial (ROLANDO, GEICO-1601).

5549 Background: The prognosis for patients with platinum-resistant/refractory ovarian cancer (PROC) is poor, and the aim of treatment is focused primarily on symptom control and maintenance of QoL. The objective of this study was to assess the impact on QoL of the combination of pegylated liposomal doxorubicin (PLD) with olaparib (OLA) in PROC patients (pts). Methods: ROLANDO is a single arm phase II trial that enrolled pts with high-grade serous or endometrioid and at least one previous PROC recurrence (between 28 days - 6 months after last platinum). Up to 4 previous lines (up to 5 in BRCA-mut) were allowed. Pts received 6 cycles of PLD 40 mg/m2 intravenously every 28 days + OLA 300 mg b.i.d. followed by OLA 300 mg b.i.d. monotherapy until progression or unacceptable toxicity. QoL was measured by European Organization for Research and Treatment of Cancer QLQ C30 questionnaire evaluating functional status, and symptom intensity and QLQ OV-28 ovarian cancer specific module, both filled out by pts every 4 months (mo) regardless of disease progression. Questionnaire compliance was reported as percentage of the initial number of pts. Changes between baseline and subsequent visits (Wilcoxon rank test) were evaluated. P values &lt; 0.05 were considered significant. Results: From 2017 to 2020, 31 pts were recruited. Median age was 57 y.o., ECOG 0/1: 32.3%/67.7%. Median of prior lines was 2 (range 1-5) and pts were on study treatment for a median of 5 mo (range 1.4-19.5) for OLA and 5 cycles (range 2 - 6) for PLD. QoL information was available at baseline for 30 (97%) pts and decayed to 22 (71%), 13 (42%), 6 (19%) and 4 (13%) pts at 4, 8, 12, and 16 mo respectively. Global health status measured by QLQ C30 and QLQ OV-28 scores was maintained throughout all time points with no significant differences. Significant transient improvement was seen in social functioning after 12 mo (p = 0.013). Nausea-vomiting (p = 0.02), hair loss (p = 0.012) and constipation (p = 0.037) showed a significant increase at 4 mo overlapping with PLD administration, and returned to baseline levels afterwards. This was in line with the reported adverse reactions frequency of nausea (58.1%) and vomiting (45.2%). Dyspnea showed a transient significant increase at 12 mo (p = 0.012), whereas insomnia (p = 0.038) and attitude towards disease (p = 0.007) improved at 16 mo. Symptoms such as appetite and constipation did not change after 12 mo. Most functional scales (physical, role, emotional, cognitive, body, sexuality) and symptom scales (fatigue, pain, appetite loss, diarrhoea, neurologic, hormonal and economic burden) had no statistically significant changes. Conclusions: Pts treated with OLA+PLD combination reported no signs of clinically relevant deterioration of QoL while on treatment. All QoL items changes were transient in no more than 1 time-point. Clinical trial information: NCT03161132.

Efficacy of Plinabulin vs Pegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Adults With Non–Small Cell Lung Cancer

Plinabulin is a novel, non-granulocyte colony-stimulating factor (GCSF) small molecule with both anticancer and neutropenia-prevention effects. To assess the efficacy and safety of plinabulin compared with pegfilgrastim for the prevention of chemotherapy-induced neutropenia following docetaxel chemotherapy in patients with non-small lung cancer. This was a randomized, open-label, phase 2 clinical trial of 4 treatment arms that was conducted in 19 cancer treatment centers in the United States, China, Russia, and Ukraine. Participants were adult patients with non-small cell lung cancer whose cancer had progressed after platinum-based chemotherapy. Data were collected from April 2017 through March 2018 and analyzed from August 2019 through February 2020. All patients received docetaxel 75 mg/m2 on day 1 and were randomly assigned to 1 of 3 doses of plinabulin (5, 10, or 20 mg/m2) on day 1 or to pegfilgrastim 6 mg on day 2. Patients were treated every 21 days for 4 chemotherapy cycles. The primary end point was the determination of the recommended phase 3 dose of plinabulin based on the days of severe neutropenia during chemotherapy cycle 1. Daily complete blood cell counts and absolute neutrophil counts were drawn during times of anticipated neutropenia during cycle 1. Of the 55 patients randomized and evaluated, the mean (SD) age was 61.3 (10.2) years, and 38 (69.1%) were men. With each escalation of the plinabulin dose, the incidence of any grade of neutropenia decreased. There were no significant differences in mean (SD) days of severe neutropenia among those treated with pegfilgrastim (0.15 [0.38] days) when dosed at day 2 vs plinabulin 20 mg/m2 (0.36 [0.93] days; P = .76) when dosed at day 1, and no safety signals were detected. Single dose-per-cycle plinabulin has a similar neutropenia protection benefit as pegfilgrastim. Plinabulin 40 mg fixed dose, which is pharmacologically equivalent to 20 mg/m2, will be compared with pegfilgrastim 6 mg in the phase 3 portion of this trial. Noninferior days of severe neutropenia will be the primary end point, and bone pain reduction, thrombocytopenia reduction, and quality of life maintenance will be secondary end points. ClinicalTrials.gov Identifier: NCT03102606.

P-98 HGCSG1902: Multicenter, prospective, observational study for cases with dysgeusia caused by chemotherapy for gastrointestinal cancer

Anti-tumor agents have been developing every year, and the overall survival in gastrointestinal cancer patients is dramatically improved in a decade. As the duration of treatment prolongs, quality of life (QoL) and management for adverse events have become increasingly important. Diet is an important factor in QoL maintenance, but it is known that adverse events of chemotherapy include anorexia, nausea, vomiting, and dysgeusia, which can lead to reduced oral intake. The incidence of dysgeusia associated with chemotherapy is reported to be approximately 56-76%, depending on the type of chemotherapy. Prolonged dysgeusia may worsen nutritional status and performance status. Nausea and vomiting can be treated with an antiemesis, but there has been no promising intervention for dysgeusia for a long time. The mechanism of chemotherapy-induced dysgeusia is not yet clear, but it has been reported that cells with rapid turnover, such as taste bud cells, are more sensitive to chemotherapy than other cells. Furthermore, it has been demonstrated that the regeneration of taste bud cells requires large amounts of zinc. Therefore, zinc deficiency can cause dysgeusia. Cytotoxic agents may act as a chelator for zinc. However, there are no prospective multicenter studies of the effects of zinc administration on dysgeusia caused by chemotherapy. By analysing various factors related to dysgeusia due to chemotherapy, we can identify the factors associated with dysgeusia and clarify the effectiveness of zinc preparations, which will contribute to the establishment of supportive care for patients undergoing chemotherapy. Therefore, we planned a multicenter, prospective observational study on cases of dysgeusia caused by chemotherapy for gastrointestinal cancer. This study is carried out as an investigator-initiated, multicenter, prospective observational study to determine clinical or treatment factors associated with chemotherapy-related dysgeusia in patients with advanced gastrointestinal cancer. Eligibility criteria include patients presenting grade 1 or more dysgeusia in Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or Scale of Subjective Total Taste Acuity (STTA) during chemotherapy for gastrointestinal cancer. One of the important exclusion criteria is the administration of zinc preparations before presenting dysgeusia. After registration, physicians will collect clinical information related to dysgeusia prospectively for 12 weeks using blood sampling and two times questionnaires. The treatment method for dysgeusia is determined by the physician’s choice (no intervention, polaprezinc, or zinc acetate hydrate). The data to be collected in this study include changes in dysgeusia, the relationship between serum zinc levels and dysgeusia, the contribution of physical factors to dysgeusia (age, height, weight, body surface area), the involvement of nutritional factors (hemoglobin level, serum iron, albumin level) and the safety of the intervention. A total of 180 cases are planned for registration in 13 institutions. In this study, we can evaluate the effects of factors contributing to dysgeusia, and the effects of zinc preparations on improving dysgeusia. This study was approved by the institutional review board of Hokkaido University Hospital (approval number: 019-0248). Clinical trial information: UMIN000039653. We would like to express special thanks to all participating investigators. The authors.

Antiemetic prophylaxis with NEPA: Final results of the German AKYPRO study.

12095 Background: NEPA is a fixed combination antiemetic of the NK1-receptor-antagonist (RA) netupitant and the 5-HT3-RA palonosetron. Primary objective of this prospective non-interventional study in Germany was to assess quality of life of cancer patients (pts) undergoing moderately (MEC) or highly (HEC) emetogenic chemotherapy (CT) who received NEPA for prophylaxis of nausea and vomiting (CINV). Secondary objectives were patient reported outcomes as well as effectiveness and safety of NEPA. Here we report final data of the quality of life analysis. Methods: The study included 2.405 pts in 162 centers receiving 3 consecutive cycles of CT as one or two day MEC or HEC. Primary endpoint was impact of quality of life (QoL) due to vomiting or nausea, documented by Functional Living Index–Emesis (FLIE) questionnaires. Effectiveness was reported in patient diaries. Complete response (CR) was defined as no emesis and no rescue medication (RM). Non-significant nausea (NSN) was no or mild nausea. Adverse events (AEs) were reported on d1–21 of each cycle. Results: 2.173 patients were included in the final analysis (full analysis set; FAS). The majority of patients (n = 1976; 91%) received 1-day chemotherapy, 64% HEC, 36% MEC. Median age was 58 years and the majority (85%) was female. Cancer diagnoses: breast 66%, gastrointestinal 10%, ovarian 7% or lung 5%, other 12%. Chemotherapy: AC 57%, carboplatin 19%, cisplatin 8%, oxaliplatin 8% and other 8%. 84% of pts with HEC and 82% with MEC felt no impact on daily life due to vomiting in cycle 1 remaining constant in C2 and C3. 54% HEC patients and 59% MEC patients reported no impact on daily life due to nausea in cycle 1. CR rates ranged between 81-84% and were comparable between different HEC or MEC. NSN rates in MEC ranged from 75% (MEC) to 62% (HEC). Drug-related AEs were rare with constipation, fatigue, insomnia, and nausea as the most common (in &gt; 1% pts). Conclusions: NEPA was highly effective in the prevention of CINV and maintenance of QoL in this real world study. Over 80% of pts reported that their daily live was not influenced by emesis while nausea was more difficult to control. Effectiveness was high and patients and physicians estimate was comparable.

Factors related to physical and mental components of quality of life in the community-dwelling frail older persons.

[Purpose] The aim of this study was to investigate factors associated with changes in both the physical and mental components of quality of life (QOL) in of community-dwelling frail older persons in long-term care and to clarify which aspects are important to maintaining physical and mental components of QOL. [Participants and Methods] In this 1 year follow-up cohort study, participants were older persons from a single day care rehabilitation center in Japan. The Medical Outcome Study 8-Item Short-Form Health Survey (MOS-SF8), which gives both physical component summary (PCS) and mental component summary (MCS) scores, was used as the main QOL assessment. Participants were divided according to their level of QOL maintenance according to changes in PCS and MCS scores over the study period, and the variables were compared between the groups. [Results] PCS domain was significantly associated with forced vital capacity and the MCS domain was significantly associated with the Geriatric Depression Scale and Dysphagia Risk Assessment for the Community-Dwelling Elderly Test. [Conclusion] Depression, reduced pulmonary function, and reduced deglutition ability were independently related to low QOL. Assessment of these factors could be beneficial for maintaining the physical and mental components of QOL in community-dwelling frail older persons in long-term care.

Quality of life patients on hemodialysis in Kerala

Background: End Stage Renal Disease (ESRD) is on the rise in the recent years which carries with it emotional, physical, psychological, social, and existential burdens that impact their Quality of life (QOL). The QOL describes life satisfaction and life concerns and are affected by health and illness. Maintenance of QOL with the effects of chronic illness is a challenging, multifaceted, complex endeavour for patients, their families and the health professionals. Objective: To assess the kidney disease related quality of life in patients with ESRD, its association with selected demographic, socio economic, disease and treatment related characteristics of ESRD patients.&#x0D; Materials and methods: Descriptive survey was conducted on 112 participants diagnosed with ESRD and on hemodialysis at least for a minimum duration of 1 month, were recruited from both government and private hospitals through purposive sampling as per the inclusion and exclusion criteria. The Kidney Disease Quality of Life (KDQOLTM-36) and Personal Data Sheet were used to assess the QOL and to obtain information as per the objectives. Descriptive analysis and Chi square test were used to analyze the data.&#x0D; Results: Majority of the ESRD subjects had poor quality of life in all the domains, higher proportion being in the burden of illness (71.4%) and effects of illness (68.8%) domains. There was a significant association between the burden of illness and marital status(p=.01), type of bystander(p=.01); symptom and type of bystander(p=.03)&#x0D; Conclusion: Majority of the ESRD patients had low KDQOL scores indicating poor quality of life in all the domains requiring intervention. This emphasizes the need to identify as well as manage QOL among them and develop appropriate intervention

Longitudinal analysis of quality of life following treatment with Asunercept plus reirradiation versus reirradiation in progressive glioblastoma patients

PurposeGlioblastoma is an aggressive malignant cancer of the central nervous system, with disease progression associated with deterioration of neurocognitive function and quality of life (QoL). As such, maintenance of QoL is an important treatment goal. This analysis presents time to deterioration (TtD) of QoL in patients with recurrent glioblastoma receiving Asunercept plus reirradiation (rRT) or rRT alone.MethodsData from patients with a baseline and ≥ 1 post-baseline QoL assessment were included in this analysis. TtD was defined as the time from randomisation to the first deterioration in the EORTC QLQ-C15, PAL EORTC QLQ-BN20 and Medical Research Council (MRC)-Neurological status. Deterioration was defined as a decrease of ≥ 10 points from baseline in the QLQ-C15 PAL overall QoL and functioning scales, an increase of ≥ 10 points from baseline in the QLQ-C15 PAL fatigue scale and the QLQ-BN20 total sum of score, and a rating of “Worse” in the MRC-Neurological status. Patients without a deterioration were censored at the last QoL assessment. Kaplan–Meier estimates were used to describe TtD and treatment groups (Asunercept + rRT or rRT alone) were compared using the log-rank test.ResultsTreatment with Asunercept + rRT was associated with significant improvement of TtD compared with rRT alone for QLQ-CL15 PAL overall QoL and physical functioning, and MRC Neurological Status (p ≤ 0.05). In the Asunercept + rRT group, QoL was maintained beyond progresison of disease (PoD).ConclusionTreatment with Asunercept plus rRT significantly prolongs TtD and maintains QoL versus rRT alone in recurrent glioblastoma patients.

Patient-reported quality of life (QoL) of advanced melanoma patients in a Phase 3 study of nivolumab (NIVO) with or without ipilimumab (IPI) versus IPI: CheckMate 067 4-year data.

9551 Background: Early CheckMate 067 data showed maintenance of QoL in patients with advanced melanoma treated with NIVO with or without IPI based on 1-year data; however, the long-term QoL of these patients has not been evaluated previously. The patient-reported outcomes (PRO) analyses presented here for CheckMate 067 is the first time QoL results have been evaluated in this melanoma population over a 4-year period. Methods: In CheckMate 067, 945 patients were randomized 1:1:1 to receive NIVO (3mg/kg Q2W) + placebo (PBO), NIVO+IPI (1mg/kg+3mg/kg Q3W X 4) followed by NIVO (3mg/kg Q2W), or IPI (3mg/kg Q3W X 4) + PBO. PRO data were collected using the EORTC QLQ-C30 (5 functional domains, 9 symptoms, global health status) and EQ-5D-3L (utility index, VAS) at baseline, weeks 1 and 5 of each 6-week tx cycle, and off-tx follow-up (FU) visits. Mean changes in PRO scores from baseline (randomization) were evaluated descriptively for the PRO analysis population, with conclusions drawn from time points with ≥30 patients completing assessments per tx arm. Least square mean changes from baseline were assessed using a longitudinal mixed model analysis adjusting for repeated measures, including all on-tx data for patients. Results: Completion rates at baseline ranged from 89-92% across tx arms. Of 813 patients included in the PRO analysis population (278 NIVO, 274 NIVO+IPI, 261 IPI), &gt; 200 receiving tx remained for the first year, &gt; 100 receiving tx remained after 2 years, and &gt; 50 receiving tx remained after 3 years. QoL, including assessment of functioning and symptom burden, was maintained for the duration of tx and in FU, with no sustained clinically meaningful deterioration in any tx arm. Global health status (EORTC QLQ-C30) and general QoL (EQ-5D-3L VAS) were also maintained during prolonged tx. Overall, results from the mixed model analysis support the long-term maintenance of QoL over the course of tx. Conclusions: Patient-reported QoL and symptoms in patients with advanced melanoma were maintained from baseline during extended tx with NIVO with or without IPI. Clinical trial information: NCT01844505.

Quality of life (QoL) and symptom burden in patients (pts) with advanced melanoma during the treatment-free interval (TFI) after discontinuation of nivolumab (NIVO) or NIVO plus ipilimumab (IPI).

9568 Background: The TFI after discontinuation of study therapy has been reported to be longer with NIVO+IPI compared to NIVO or IPI alone, but QoL during the TFI has not been reported in advanced melanoma (MEL) studies. 1-y data from CheckMate (CM) 067 showed maintenance of QoL after treatment (tx) discontinuation with NIVO or NIVO+IPI. Here, we present long-term QoL results from CM 067 during the TFI (period off study tx and free of subsequent therapy), based on an updated 4-y dataset. Methods: In CM 067, 945 pts were randomized 1:1:1 to receive NIVO 3 mg/kg + placebo; NIVO 1 mg/kg + IPI 3 mg/kg × 4, then NIVO 3 mg/kg; or IPI 3 mg/kg × 4 + placebo. Patient-reported outcomes (PRO) were collected using the EORTC QLQ-C30 (5 functional domains, 9 symptoms, global health status) and EQ-5D-3L (utility index, visual analog scale) at baseline, on-tx visits, and follow-up (FU) visits 1 (FU1; 30 d after last dose) and 2 (FU2; 84 d after FU1). EQ-5D-3L was also collected at survival FU visits every 3 mo after FU2 in the first year and every 6 mo thereafter. Within the PRO analysis population, 480 of 764 pts who discontinued protocol tx (for any reason, including drug toxicity; n = 155) had PRO scores, collected prior to initiation of subsequent anticancer therapy, evaluated. Mean changes in PRO scores from last on-tx visit were reported for each FU visit. Results: Across tx arms, PRO scores were maintained from last on-tx visit to FU1 or FU2 for pts who discontinued for any reason. EORTC QLQ-C30 functional and symptom scales remained stable during the TFI. Among pts who discontinued tx due to toxicity, clinically meaningful deterioration in QoL was observed in a few subscales at FU1, but QoL was restored to the same level as the last on-tx visit in all except one subscale by FU2. PRO scores remained stable beyond FU2 for the EQ-5D-3L, regardless of reason for discontinuation. Data interpretation at later FU visits was limited due to smaller sample sizes. Sensitivity analyses for mean change in PRO scores from randomization to FU visits will be presented. Conclusions: QoL was maintained during the TFI, compared to last on-tx visit, in pts with MEL treated with NIVO or NIVO+IPI.

A pilot study of patient reported outcomes evaluating treatment related symptoms and quality of life for men receiving high dose rate brachytherapy combined with hypo-fractionated radiotherapy or hypo-fractionated radiotherapy alone for the treatment of localised prostate cancer.

Patient Reported Outcome Measures (PROMS) are useful metrics in evidence-based clinical care and translational research. Recording treatment-related symptoms and Quality of Life (QoL) can provide information in counselling patients to aid decision-making. This prospective study tested the feasibility of radiographer-led collection of multiple validated PROMS from Prostate Cancer (PCa) patients comparing High Dose Rate Brachytherapy combined with hypo-fractionated external beam radiotherapy (hEBRT) and hEBRT alone. From June to August 2017, 20 men with localised PCa (T1-T3aN0M0) consented to participate in the study. Ten patients received combination treatment (37.5 Gray/15 fractions followed by a 15 Gray implant), and ten patients received monotherapy (60 Gray/20 fractions). PROMS were collected at four time-points (1) at baseline, (2) final fraction of hEBRT, (3) 8 weeks after commencing radiotherapy and (4) 12 weeks after commencing radiotherapy. The PROMS used were EPIC-26, IPSS, IIEFF-5 and SF-12. The difference between the two groups were tested using Mann-Whitney U test and Wilcoxon Signed-Rank Test. All participants completed all PROMS (100% response-rate). The Monotherapy group reported a higher incidence of bowel symptoms compared to the combination group and at Week 12, EPIC-26 bowel summary score demonstrated a statistically significant difference (p = 0.005). The prevalence of erectile dysfunction increased within both groups. Maintenance of QoL was reported throughout treatment. This small study demonstrated feasibility of radiographer-led PROMS collection by 100% completion rate. Streamlining of these tools into integrated technology applications and real time PROMS measurement has the ability to benefit patients and guide clinicians in adapting therapies based on individual need.